Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System
- UID
- IMP/MD/2023/001148_c040b8e276471b6ad750f3f11f799984_c559b52bd84f08aa76cb24c09f7e4de0
- Device class
- Class C
- Brand name
- TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System
- License holder
- Johnson & Johnson Surgical Vision India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- Correction of aphakia following removal of the natural crystalline lens.The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The IOL is intended to be placed in the capsular bag only.
Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001148_c040b8e276471b6ad750f3f11f799984_c559b52bd84f08aa76cb24c09f7e4de0. This device is marketed under the brand name TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System. The license holder is Johnson & Johnson Surgical Vision India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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